Table 2.
Hemagglutinin Inhibition (HI) Antibodies Against A/Turkey/Turkey/01/2005(H5N1) and A/Indonesia/5/2005(H5N1), by Age, in the Per Protocol Cohorts for Immunogenicity
| Vaccine, Age, Time Pointa | SC Rate/BSC Rateb |
SP Ratec |
MGI/BFd |
|
|---|---|---|---|---|
| Subjects, No. | Subjects, % (95% CI) | Subjects With a Titer ≥ 1:40, % (95% CI) | Value (95% CI) | |
| A/turkey/Turkey/01/2005(H5N1) | ||||
| 6 to <12 mo | ||||
| Before | 33 | … | 0.0 (0.0; 10.6) | … |
| Day 182 | 33 | 93.9 (79.8; 99.3) | 93.9 (79.8; 99.3) | 16.5 (12.8; 21.4) |
| Day 192 | 33 | 97.0 (84.2; 99.9) | 100 (89.4; 100) | 25.7 (18.4; 35.7) |
| Day 364 | 41 | 100 (91.4; 100) | 100 (91.4; 100) | 19.9 (15.2; 26.1) |
| 12 to <24 mo | ||||
| Before | 24 | … | 0.0 (0.0; 14.2) | … |
| Day 182 | 21 | 95.2 (76.2; 99.9) | 100 (83.9; 100) | 14.8 (10.8; 20.1) |
| Day 192 | 21 | 100 (83.9; 100) | 100 (83.9; 100) | 21.5 (16.4; 28.2) |
| Day 364 | 26 | 100 (86.8; 100) | 100 (87.2; 100) | 16.4 (12.6; 21.4) |
| 24 to <36 mo | ||||
| Before | 29 | … | 3.4 (0.1; 17.8) | … |
| Day 182 | 29 | 96.6 (82.2; 99.9) | 100 (88.1; 100) | 15.6 (12.5; 19.5) |
| Day 192 | 29 | 100 (88.1; 100) | 100 (88.1; 100) | 20.5 (16.2; 26.1) |
| Day 364 | 32 | 87.5 (71.0; 96.5) | 100 (89.1; 100) | 9.5 (7.2; 12.5) |
| All | ||||
| Before | 86 | … | 1.2 (0.0; 6.3) | … |
| Day 182 | 83 | 95.2 (88.1; 98.7) | 97.6 (91.6; 99.7) | 15.8 (13.6; 18.2) |
| Day 192 | 83 | 98.8 (93.5; 100) | 100 (95.7; 100) | 22.7 (19.3; 26.8) |
| Day 364 | 99 | 96.0 (90.0; 98.9) | 100 (96.4; 100) | 14.9 (12.6; 17.6) |
| A/Indonesia/5/2005(H5N1) | ||||
| 6 < 12 mo | ||||
| Before | 33 | … | 0.0 (0.0; 10.6) | … |
| Day 42 | 32 | 100 (89.1; 100) | 100 (89.1; 100) | 189.0 (149.2; 239.6) |
| Day 182 | 33 | 97.0 (84.2; 99.9) | 97.0 (84.2; 99.9) | 32.0 (25.1; 40.8) |
| Day 192 | 33 | 100 (89.4; 100) | 100 (89.4; 100) | 432.8 (354.5; 528.3) |
| Day 364 | 41 | 100 (91.4; 100) | 100 (91.4; 100) | 293.1 (233.6; 367.6) |
| 12 < 24 mo | ||||
| Before | 24 | … | 0.0 (0; 14.2) | … |
| Day 42 | 24 | 100 (85.8; 100) | 100 (85.8; 100) | 267.3 (198.1; 360.8) |
| Day 182 | 21 | 100 (83.9; 100) | 100 (83.9; 100) | 29.5 (22.6; 38.3) |
| Day 192 | 21 | 100 (83.9; 100) | 100 (83.9; 100) | 306.9 (221.6; 425.1) |
| Day 364 | 27 | 100 (87.2; 100) | 100 (87.2; 100) | 211.2 (153.8; 289.8) |
| 24 < 36 mo | ||||
| Before | 29 | … | 0.0 (0; 11.9) | … |
| Day 42 | 29 | 100 (88.1; 100) | 100 (88.1; 100) | 208.9 (166.5; 262.2) |
| Day 182 | 29 | 100 (88.1; 100) | 100 (88.1; 100) | 26.7 (22.6; 31.6) |
| Day 192 | 29 | 100 (88.1; 100) | 100 (88.1; 100) | 321.2 (250.9; 411.4) |
| Day 364 | 32 | 100 (89.1; 100) | 100 (89.1; 100) | 133.7 (101.0; 176.8) |
| All | ||||
| Before | 86 | … | 0.0 (0.0; 4.2) | … |
| Day 42 | 85 | 100 (95.8; 100) | 100 (95.8; 100) | 215.7 (187.1; 248.7) |
| Day 182 | 83 | 98.8 (93.5; 100) | 98.8 (93.5; 100) | 29.4 (25.9; 33.4) |
| Day 192 | 83 | 100 (95.7; 100) | 100 (95.7; 100) | 357.5 (310.5; 411.7) |
| Day 364 | 100 | 100 (96.4; 100) | 100 (96.4; 100) | 208.7 (177.2; 245.7) |
Abbreviations: BF, booster factor; BSC, booster seroconversion; CI, confidence interval; MGI, mean geometric increase; SC, seroconversion.
a “Before” denotes before vaccination; “day 42,” 21 days after dose 2; “day 182,” before booster; “day 192,” 10 days after the booster; and “day 364,” 6 months after the booster.
b A/turkey/Turkey/01/2005(H5N1) only: percentage of seronegative participants with a postvaccination/booster titer of ≥1:40 or the percentage of initially seropositive participants with a ≥4-fold increase in titer.
c The seroprotection (SP) rate is defined as the percentage with HI antibody titer of ≥1:40.
d A/turkey/Turkey/01/2005(H5N1) only: geometric mean of the within-subject ratios of the postvaccination/postbooster reciprocal HI titer to the prevaccination/prebooster reciprocal HI titer.